NCT04745572.
| Study name | Development of an adaptive treatment for weight loss in people with prediabetes |
| Methods | Randomised trial (sequential assignment) |
| Participants | Adults aged 18 to 75 years, with a BMI of ≥ 27 kg/m2 and at risk for developing type 2 diabetes mellitus (prediabetes). Exclusion criteria included: pregnancy, planned pregnancy or breastfeeding; or uncontrolled hypo‐ or hyperthyroidism. |
| Interventions | Intervention ‐ Reduced‐carbohydrate diet: response assessed at four weeks on a State of Slim (SOS) weight management programme combined with a reduced‐carbohdyrate (RC) diet; responders to continue and non‐responders re‐randomised to RC with time‐restricted eating (TRE) or RC with structured exercise counselling sessions. Control ‐ High‐carbohydrate diet: response assessed at four weeks on a State of Slim (SOS) weight management programme combined with a high‐carbohdyrate (HC) diet; responders to continue and non‐responders re‐randomised to HC with time‐restricted eating (TRE) or HC with structured exercise counselling sessions |
| Outcomes | Primary outcomes: 1) change in body weight, 2) change in glucose, 3) change in insulin, 4) change in lipids, 5) change in fat mass, 6) changes in QUICKI index (predictor of insulin resistance) Secondary outcomes: 1) change in overall strength, 2) change in aerobic fitness, 3) diet intake and physical activity monitoring |
| Starting date | May 2021 |
| Contact information | Chelsi Reynolds, cnreynolds@uabmc.edu and Drew Sayer, sayerd@uab.edu |
| Notes | Prospectively registered |
BMI: body mass index CHO: carbohydrate DASH: Dietary Approaches to Stop Hypertension DNA: deoxyribonucleic acid DPP‐GLB: Diabetes Prevention Program‐Group Lifestyle Balance GFR: glomerular filtration rate GLOH: Giving a low carbohydrate diet to overcome hypertension (trial acronym) GLP‐1: glucagon‐like peptide‐1 HbA1c: haemoglobin A1c/glycated haemoglobin HC: high‐carbohydrate HDL: high‐density lipoprotein(‐cholesterol) HP: high‐protein LDL: low‐density lipoprotein(‐cholesterol) LION: Lifestyle intervention study for weight loss maintenance (trial acronym) MED: Mediterranean MUFA: monounsaturated fatty acid NYHA: New York Heart Association OTC: over‐the‐counter PUFA: polyunsaturated fatty acid RC: reduced‐carbohydrate SD: standard deviation SGLT: sodium‐glucose cotransporter SOS: State of Slim T2D: type 2 diabetes TRE: time‐restricted eating TSH: thyroid stimulating hormone VLC: very low‐carbohydrate WC: waist circumference WELCOME: Diet for the maintenance of weight loss and metabolic health in obese postmenopausal women (trial acronym)